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NCT07623200PHASE3Recruiting

A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia

Incyte Corporation

Start Date

9/8/2026

Completion Date

11/1/2030

Summary

This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Confirmed diagnosis of high-risk ET. * Presence of mutCALR. * Prior treatment with at least 1 cytoreductive therapy. Exclusion Criteria: * Presence of any hematologic malignancy other than ET. * Major bleeding or thrombosis within the last 3 months prior to study enrollment. * Any prior allogenic or autologous stem-cell transplantation. * Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy. * Prior nonhematologic malignancy except for the following: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease. Other protocol-defined Inclusion/Exclusion Criteria apply.

Interventions

DRUG

INCA033989

DRUG

Best Available Treatment

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Conditions

Essential Thrombocythemia

Locations

University of Alabama At Birmingham Comprehensive Cancer Center

Birmingham, Alabama 35205

United States

Banner Md Anderson Cancer Center

Gilbert, Arizona 85234

United States

City of Hope Medical Center

Duarte, California 91010

United States

Marin Cancer Care

Greenbrae, California 94904

United States

University of California, Los Angeles Medical Center

Los Angeles, California 90095

United States

Stanford Cancer Center

Palo Alto, California 94304

United States

Rocky Mountain Cancer Centers-Lone Tree

Lone Tree, Colorado 80124

United States

Medstar Georgetown Medical Center, Inc

Washington D.C., District of Columbia 20007

United States

Florida Cancer Specialists & Research Institute

Fort Myers, Florida 33901

United States

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

Cleveland Clinic

Weston, Florida 33331

United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois 60611

United States

University of Chicago

Chicago, Illinois 60637

United States

The University of Kansas Cancer Center

Westwood, Kansas 66205

United States

Our Lady of the Lake Medical Center

Baton Rouge, Louisiana 70808

United States

Johns Hopkins Medicine-the Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland 21231

United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland 21044

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center (Bidmc)

Boston, Massachusetts 02215

United States

University of Massachusetts Medical School

Worcester, Massachusetts 01655

United States

University of Michigan Rogel Cancer Center Adult Bone Marrow Transplant Clinic

Ann Arbor, Michigan 48109-4000

United States

Missouri Cancer Associates

Columbia, Missouri 65201

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Icahn School of Medicine At Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Weill Cornell Medical College - Newyork-Presbyterian Hospita

New York, New York 10065

United States

Strong Memorial Hospital University of Rochester Medical Center

Rochester, New York 14642

United States

Duke University Medical Center

Durham, North Carolina 27705

United States

Cleveland Clinic Taussig Cancer Ctr

Cleveland, Ohio 44195

United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon 97401

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Thomas Jefferson University Sidney Kimmel Medical College

Philadelphia, Pennsylvania 19107

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232-5735

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Baylor Charles A. Sammons Cancer Center

Dallas, Texas 75246

United States

The University of Texas-Md Anderson Cancer Center

Houston, Texas 77030

United States

Ut Health Science Center At San Antonio

San Antonio, Texas 78229

United States

Texas Oncology-Tyler

Tyler, Texas 75702

United States

Huntsman Cancer Institute At University of Utah

Salt Lake City, Utah 84112

United States

Virginia Oncology Associates (Brock Cancer Center)

Norfolk, Virginia 23502

United States

University of Washington - Fred Hutch Cancer Center

Seattle, Washington 98109

United States

Blacktown Cancer & Haematology Centre-Blacktown Hospital

Blacktown, New South Wales 02148

Australia

Gosford Hospital (Gh) - Central Coast Cancer Centre

Gosford, New South Wales 02250

Australia

Liverpool Hospital - South Western Sydney Local Health District

Liverpool, New South Wales 02170

Australia

Sunshine Coast University Hospital

Birtinya, Queensland 04575

Australia

Royal Brisbane and Women'S Hospital

Brisbane, Queensland 04029

Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria 03000

Australia

Box Hill Hospital

Melbourne, Victoria 03128

Australia

Rockingham General Hospital

Cooloongup, 06168

Australia

The Canberra Hospital

Garran, 02605

Australia

Royal Perth Hospital

Perth, 06000

Australia

Lkh - Medizinische Universitaet Graz

Graz, 08036

Austria

Landeskrankenhaus (Lkh) Leoben - Standort Leoben

Leoben, 08700

Austria

Ordensklinikum Linz Gmbh Elisabethinen

Linz, 04020

Austria

Medizinische Universitaet Wien, Akh Wien

Vienna, 01090

Austria

Klinikum Wels-Grieskirchen Gmbh

Wels, 04600

Austria

Jules Bordet Lnstitute

Anderlecht, 01070

Belgium

Centre Hospitalier Universitaire (Chu) Brugmann (Brugmann University Hospital (Uh)) - Victor Horta

Brussels, 1020

Belgium

Universitair Ziekenhuis Leuven

Leuven, 03000

Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 04000

Belgium

Algemeen Ziekenhuis Deltaaretaie

Roeselare, 08800

Belgium

Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, 01200

Belgium

St. Paul'S Hospital (Sph), Providence Health Care, University of British Columbia

Vancouver, British Columbia V6Z 1Y6

Canada

Margaret and Charles Juravinski Cancer Center

Hamilton, Ontario L8V 5C2

Canada

Queens University, Kingston General Hospital (Kgh), Kingston Health Sciences Centre (Khsc)

Kingston, Ontario K7L 2V7

Canada

University Health Network (Uhn) - Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

McGill University Health Centre - Glen Site, Centre For Innovative Medicine

Montreal, Quebec H4A 3J1

Canada

Hotel-Dieu de Levis

Québec, Quebec G6V 3Z1

Canada

Fakultni Nemocnice Brno

Brno, 625 00

Czechia

Fakultni Nemocnice Ostrava

Ostrava-poruba, 708 52

Czechia

Faculty Hospital Kralovske Vinohrady

Prague, 100 34

Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, 12808

Czechia

Ustav Hematologie A Krevni Transfuze (Uhkt)

Prague, 12820

Czechia

Chu D'Amiens-Picardie - Hopital Sud

Amiens, 80054

France

Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

Bordeaux, 33076

France

Chu de Brest Hopital de La Cavale Blanche Cic Hematologie

Brest, 29200

France

Hospital Henri Mondor

Créteil, 94000

France

Hopital Bicetre - Paris Sud (Ap-Hp)

Le Kremlin-Bicêtre, 94275

France

Centre Hospitalier Universitaire de Nice,Hopital L Archet

Nice, 06200

France

Hospital Saint-Louis - Aphp

Paris, 75010

France

Centre Hospitalier Universitaire de Poitiers La Miletrie

Poitiers, 86021

France

Institut Claudius Regaud Cancer Comprehensive Center - Iuct Oncopole

Toulouse, 31059

France

Uniklinik Rwth Aachen Medizinische Klinik Iv

Aachen, 52074

Germany

Charite - Universitaetsmedizin Berlin

Berlin, 10117

Germany

Bag Onkologische Gemeinschaftspraxis Illmer, Jacobasch, Wolf, Freiberg-Richter Fae Fur Innere Medizi

Dresden, 01307

Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106

Germany

Universitaetsklinikum Halle

Halle, 06120

Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246

Germany

Medizinische Hochschule Hannover, Hannover Medical School

Hanover, 30625

Germany

Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

Homburg, 66421

Germany

Universitaetsklinikum Jena

Jena, 07747

Germany

Universitaetsklinikum Schleswig-Holstein (Uksh) - Campus Luebeck

Lübeck, 23562

Germany

Medizinische Fakultaet Mannheim Der Universitaet Heidelberg

Mannheim, 68167

Germany

Johannes Wesling Klinikum Minden

Minden, 32429

Germany

Semmelweis University-Internal Medicine and Haematology

Budapest, 01088

Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, 04032

Hungary

University of Pecs

Pécs, 07624

Hungary

Aou Policlinico Consorziale Bari - Uo Ematologia Con Trapianto

Bari, 70124

Italy

Asst Papa Giovanni Xxiii (Azienda Ospedaliera Papa Giovanni Xxiii)

Bergamo, 24127

Italy

Istituto Di Ematologia L. E A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola Mal

Bologna, 40138

Italy

Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco

Catania, 95123

Italy

Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (Aouc)

Florence, 50134

Italy

Irccs - Azienda Ospedaliera Universitaria - Ist San Martino

Genova, 16132

Italy

Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori, Ematologia

Meldola, 47014

Italy

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico Di Milano

Milan, 20122

Italy

Ao Maggiore Della Carita

Novara, 28100

Italy

Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo

Pavia, 27100

Italy

Ospedale S. Eugenio

Rome, 00144

Italy

Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma

Rome, 00161

Italy

Universita Cattolica Del Sacro Cuore - Policlinico Universitario Agostino Gemelli

Rome, 00168

Italy

Ao Ordine Mauriziano Di Torino

Torino, 10128

Italy

Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia

Udine, 33100

Italy

Universita Degli Studi Di Verona

Verona, 37100

Italy

Juntendo University Hospital

Bunkyō City, 113-8431

Japan

Nippon Medical School Hospital

Bunkyō City, 113-8603

Japan

University of Yamanashi Hospital

Chūō, 409-3898

Japan

Kyushu University Hospital

Fukuoka, 812-8582

Japan

Fukushima Medical University Hospital

Fukushima, 960-1295

Japan

Kansai Medical University Hospital

Hirakata, 5731191

Japan

Kagoshima University Hospital

Kagoshima, 890-8520

Japan

National Cancer Center Hospital East

Kashiwa-shi, 277-8577

Japan

Kobe City Medical Center General Hospital

Kobe, 650-0047

Japan

University of Miyazaki Hospital

Miyazaki, 889-1692

Japan

Osaka Metropolitan University Hospital

Osaka, 545-8586

Japan

Kindai University Hospital

Sakai, 590-0197

Japan

Tokyo Medical University Hospital

Shinjuku-ku, 160-0023

Japan

Ehime University Hospital

Tōon, 791-0295

Japan

Mie University Graduate School of Medicine

Tsu, 514-8507

Japan

Amsterdam Universitair Medisch Centrum, Locatie Amsterdam Medisch Centrum

Amsterdam, 1105 AZ

Netherlands

University Medical Center Groningen

Groningen, 9713 GZ

Netherlands

Radboud University Medical Center

Nijmegen, 6525 GA

Netherlands

Erasmus University Medical Center

Rotterdam, 3015 GD

Netherlands

Universitair Medisch Centrum Utrecht (Umc Utrecht)

Utrecht, 3584 CX

Netherlands

Haukeland University Hospital

Bergen, 05021

Norway

Uniwersyteckie Centrum Kliniczne (Uck)

Gdansk, 80-952

Poland

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie

Krakow, 31-501

Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopernika W Lodzi

Lodz, 93-513

Poland

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

Lublin, 20-081

Poland

Instytut Hematologii I Transfuzjologii (Iht) (Institute of Haematology and Transfusion Medicine)

Warsaw, 02-776

Poland

Specjalistyczny Szpital Im. Dr Alfreda Sokolowskiego

Wałbrzych, 58-309

Poland

Pusan National University Hospital (Pnuh)

Busan, 49241

South Korea

Seoul National University Bundang Hospital (Snubh)

Seongnam-si, 13620

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

The Catholic University of Korea Seoul St. Mary'S Hospital

Seoul, 06591

South Korea

Hospital General Unviersitario de Alicante

Alicante, 03010

Spain

Hospital Universitario Vall D'Hebron

Barcelona, 08035

Spain

Hospital Clinic de Barcelona (Hospital Clinic I Provincial)

Barcelona, 08036

Spain

Hospital Universitario de Basurto

Bilbao, 48013

Spain

Instituto Catalan de Oncologia - Hospital Duran I Reynals

L'Hospitalet de Llobregat, 08908

Spain

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, 35010

Spain

Hospital Universitario Ramon Y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, 28222

Spain

Hospital Universitario Virgen de La Victoria

Málaga, 29010

Spain

Hospital Universitari Son Espases

Palma, 07120

Spain

Hospital Clinico Universitario de Salamanca

Salamanca, 37007

Spain

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, 15706

Spain

Hospital Universitario Doctor Peset

Valencia, 46017

Spain

Hospital Universitario Miguel Servet ( Hospital Infantil)

Zaragoza, 05009

Spain

University Hospital Bern (Inselspital)

Bern, 03010

Switzerland

Hoch Health Ostschweiz, Kantonsspital St. Gallen

Sankt Gallen, 09007

Switzerland

Center of Oncology, Hematology and Transfusionmedicine

Tellstrasse, 05001

Switzerland

Universitatsspital Zurich

Zurich, 08091

Switzerland

Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust

Cambridge, CB2 0QQ

United Kingdom

Western General Hospital - Lothian Health Board

Edinburgh, EH4 2XU

United Kingdom

Northwick Park Hospital - London North West University Healthcare Nhs Trust

Harrow, HA1 3UJ

United Kingdom

St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust

Leeds, LS9 7TF

United Kingdom

Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

London, SE1 9RT

United Kingdom

Northern Centre For Cancer Care - the Newcastle Upon Tyne Hospitals Nhs Foundation Trust

Newcastle upon Tyne, NE7 7DN

United Kingdom

Cancer and Haematology Centre-the Churchill Hospital-Oxford University Hospitals

Oxford, OX3 7LJ

United Kingdom

Royal Cornwall Hospital - Royal Cornwall Hospitals Nhs Trust

Penzance, TR18 2PF

United Kingdom